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Certification
Opto Circuits gets US FDA Approval for its New Generation Pulse Oximeters
 Opto
Circuits (India) Limited (OCI), India's leading manufacturer of medical diagnostics
and interventional products, recently received Section 510(K) US FDA (United
States Food & Drug Administration) approval on two of its new generation
range of pulse oximeters. The latest certification enables OCI to market its
M30 and M34 models of pulse oximeters in the United States, which is the largest
market for these products. A pulse oximeter is a non-invasive diagnostic device
for detecting the pulse rate and percentage of hemoglobin (Hb) that is saturated
with arterial oxygen.
Mediaid, the 100 per cent subsidiary of OCI, will begin marketing the product
within the US. The global market size for pulse oximeters is estimated to be
around $800 million.
The M30 and M34 models are already being successfully marketed in European and
Asian countries.
Model 30 has bright LED display visible in most lighting conditions and comes
with bar graph displays for pulse amplitude and perfusion quality indication.
The in-built rechargeable lithium ion battery runs the oximeter for approximately
18 hours. While, M34 enables data to be printed or transmitted to a computer
via the infrared port or the USB port. It also performs approximately 24 hours
of operation on a single rechargeable lithium ion battery (sleep mode).
EH News Bureau
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